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Showing 1151 - 1200Novel Treatments Emerge for Patients With Lower-Risk Myelodysplastic Syndromes
Patients with lower-risk myelodysplastic syndromes (MDS) who are dependent on red blood cell transfusions have limited options, especially if they are no longer responding to erythropoiesis-stimulating agents. Research presented during the virtual edition of the 25th European Hematology Association ...
FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...
FDA Grants Accelerated Approval to Belantamab Mafodotin-blmf for Pretreated Patients With Relapsed or Refractory Multiple Myeloma
On August 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep), an anti-B-cell maturation antigen antibody-drug conjugate, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies,...
FDA Approves Tafasitamab-cxix Combined With Lenalidomide to Treat Adults With Relapsed/Refractory DLBCL
On July 31, the U.S. Food and Drug Administration (FDA) approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified, including DLBCL arising from low-grade...
FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma
On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive...
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma
On July 24, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus), a CD19-directed genetically modified autologous T-cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. “Tremendous...
Lurbinectedin in Previously Treated Metastatic Small Cell Lung Cancer
On June 15, 2020, the alkylating drug lurbinectedin was granted accelerated approval for treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-based chemotherapy.1,2 Supporting Efficacy Data Accelerated approval was based on...
Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma
On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...
Pembrolizumab for Adult and Pediatric Patients With Tumor Mutational Burden–High Solid Tumors
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 16, 2020, pembrolizumab was granted accelerated...
In Case You Missed It: Quick Takes on Novel Therapies for Solid and Hematologic Malignancies
Because of the COVID-19 pandemic, oncology providers from around the world had to forgo their annual trip to McCormick Place—but the show did go on. We all realized important research can still be presented, clinicians and fellow researchers will still listen, and ASCO presentations will still...
Monumental Progress in the Treatment of Diffuse Large B-Cell Lymphoma
Some monuments are difficult to topple. At least that was the case dating back to 1976, when investigators from the Southwest Oncology Group demonstrated the importance of doxorubicin in the treatment of patients with a group of lymphoid malignancies then referred to as diffuse aggressive...
FDA Pipeline: Novel Treatments for Hematologic Malignancies
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to pembrolizumab for the second-line treatment of patients with relapsed or refractory Hodgkin lymphoma, and also accepted a supplemental new drug application for selinexor for pretreated patients with multiple myeloma....
Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations
On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of...
Elderberry
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Yen Nien Hou, PharmD, DiplOM, LAc, and Jyothirmai Gubili, MS, focus on...
New Recommendations Offer Guidance for Clinicians and Patients on Genetic Testing for Prostate Cancer
An international panel of experts led by researchers and thought leaders at the Sidney Kimmel Cancer Center–Jefferson Health (SKCC) and the Department of Urology at Jefferson have published the first multidisciplinary, consensus-driven, prostate cancer genetic implementation framework for the...
The 21st Century Cures Act: A Look Back, a Look Ahead
It was ambitious and it was controversial, but the bipartisan 21st Century Cures Act (Cures) made it through both houses of Congress and was signed into law in December 2016. Sponsored by Representatives Diana DeGette (D-CO) and Fred Upton (R-MI), the landmark legislation funded new medical...
Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma
On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label,...
FDA Collaborating on Use of Real-World Data to Inform COVID-19 Response Effort
On June 18, 2020, the U.S. Food and Drug Administration (FDA) took an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a...
Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2...
Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications
The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in...
Daratumumab and Hyaluronidase-fihj for Multiple Myeloma
On May 1, 2020, the combination of daratumumab and hyaluronidase-fihj was approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous (SC) dosing of daratumumab.1,2 Daratumumab and hyaluronidase-fihj is for SC use only. The...
FDA Approves Oral Combination of Decitabine and Cedazuridine for Adult Patients With Myelodysplastic Syndromes
On July 7, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi) for adult patients with myelodysplastic syndromes (MDS), including the following: Previously treated and untreated de novo and secondary MDS with the following...
Longer-Term Results of Pivotal Study in Advanced Cutaneous Squamous Cell Carcinoma
New, longer-term data from a pivotal phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), were presented during the ASCO20 Virtual Scientific Program and discussed during a poster discussion.1 Danny Rischin, MD, of the Peter MacCallum Cancer Centre, Victoria, Australia, presented...
Expert Point of View: Scott N. Gettinger, MD
Discussant for the CheckMate 227 and CheckMate 9LA trials, Scott N. Gettinger, MD, of Yale Cancer Center in New Haven, Connecticut, said: “There is tremendous interest in lung cancer to combine nivolumab plus ipilimumab, driven by the melanoma experience. However, combinations of immunotherapy come ...
First-Line Nivolumab Plus Ipilimumab Shows Activity in NSCLC, With or Without Chemotherapy
Advanced non–small cell lung cancer (NSCLC) in patients whose tumors have no EGFR or ALK alterations poses a particular challenge in terms of first-line therapy. The use of nivolumab plus ipilimumab as well as nivolumab/ipilimumab plus two cycles of chemotherapy, respectively, as first-line therapy ...
Can Use of an Algorithm Improve the Accuracy and Efficiency of Cervical Cancer Screening?
In a new study published by Wentzensen et al in the Journal of the National Cancer Institute, a computer algorithm improved the accuracy and efficiency of cervical cancer screening compared with cytology (Papanicolaou [Pap] test), the current standard for follow-up of women who test positive in...
FDA Pipeline: Agents for the Treatment of Prostate and Pancreatic Cancers, Marginal Zone Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to relugolix for the treatment of advanced prostate cancer; Fast Track designation to a radioimmunotherapeutic treatment for marginal zone lymphoma; and Orphan Drug designation to a novel monoclonal antibody for...
Can Use of an Algorithm Improve the Accuracy and Efficiency of Cervical Cancer Screening?
In a new study published by Wentzensen et al in the Journal of the National Cancer Institute, a computer algorithm improved the accuracy and efficiency of cervical cancer screening compared with cytology (Papanicolaou [Pap] test), the current standard for follow-up of women who test positive in...
Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma
Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented at the ASCO20 Virtual Scientific Program by Elizabeth R. Plimack,...
FDA Approves Maintenance Avelumab for the Treatment of Advanced Urothelial Carcinoma
On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. JAVELIN Bladder 100 Efficacy of avelumab...
FDA Approves Pembrolizumab for the First-Line Treatment of MSI-H/dMMR Colorectal Cancer
On June 29, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer. KEYNOTE-177 Approval was based on...
FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer
On June 29, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection in the following indications: Use in combination with chemotherapy as: Neoadjuvant treatment for patients with...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected...
Pomalidomide for Treatment of Kaposi Sarcoma
On May 14, 2020, pomalidomide was granted accelerated approval to treat adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and for Kaposi sarcoma in adult patients who are HIV-negative.1,2 Pomalidomide is available only through the restricted...
ASCO20 Virtual Scientific Program: Next-Generation Oncology Highlights
The ASCO20 Virtual Scientific Program was different in many ways, not only because of the virtual modality forced by the COVID-19 pandemic, but also because of the resilience of the scientific society and my colleagues around the world. I’m in the plenary session of the ASCO 2025 Annual Meeting....
Brigatinib for ALK-Positive Metastatic Non–Small Cell Lung Cancer
On May 22, 2020, brigatinib was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion...
Ramucirumab Plus Erlotinib in Treatment of EGFR-Mutant Metastatic NSCLC
On May 29, 2020, ramucirumab was approved for use in combination with erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.1,2 Supporting Efficacy Data Approval was based on findings from the...
Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with...
Ripretinib in Previously Treated Advanced Gastrointestinal Stromal Tumor
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 15, 2020, the receptor tyrosine kinase inhibitor...
Newer Late-Line Treatments May Change Front-Line Standard of Care in HER2-Positive Metastatic Breast Cancer
First- and second-line treatments of HER2-positive metastatic breast cancer have become the standard of care based on solid gains in overall survival, but the prevalence of resistance to these agents is increasing; up to 55% of patients will ultimately develop brain metastases. According to a pair...
FDA Approves Pembrolizumab for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma
On June 24, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable with surgery or radiation. KEYNOTE-629 Efficacy was investigated in KEYNOTE-629, a multicenter, multicohort,...
Underrepresentation of Black Patients in Cancer Clinical Trials: Public vs Pharmaceutical Sponsorship
Black patients are better represented in taxpayer-funded cancer clinical trials compared to trials run by pharmaceutical companies, although they remain underrepresented in clinical trials, regardless of sponsor. These results were published by Joseph M. Unger, PhD, and colleagues in JNCI Cancer...
FDA Announces Project Patient Voice to Communicate Patient-Reported Outcomes From Cancer Clinical Trials
The U.S. Food and Drug Administration (FDA) has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer ...
FDA Approves Selinexor for Relapsed or Refractory DLBCL
On June 22, the U.S. Food and Drug Administration (FDA) approved oral selinexor (Xpovio), a first-in-class, selective inhibitor of nuclear export compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified after at least...
Expert Point of View: Scott N. Gettinger, MD
Discussant for the CheckMate 227 and CheckMate 9LA trials, Scott N. Gettinger, MD, of Yale Cancer Center in New Haven, Connecticut, said: “There is tremendous interest in lung cancer to combine nivolumab plus ipilimumab, driven by the melanoma experience. However, combinations of immunotherapy come ...
Positive Findings in NSCLC for First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy
It is becoming more challenging to select first-line therapy for advanced non–small cell lung cancer (NSCLC) for patients whose tumors have no EGFR or ALK alterations. The results of two different studies presented at the ASCO20 Virtual Scientific Program—CheckMate 227 and CheckMate 9LA—support the ...
FDA Pipeline: Fast Track Designations in Colorectal and Pancreatic Cancers, Lymphoplasmacytic Lymphoma/Waldenström’s Macroglobulinemia
Over the past month, the U.S. Food and Drug Administration has granted Fast Track designation to agents designed to treat colorectal and pancreatic cancers, in addition to lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; accepted a new drug application for a treatment for relapsed or...
FDA Grants Accelerated Approval to Tazemetostat for Some Patients With Follicular Lymphoma
On June 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have...
FDA Approves Pembrolizumab for Adults and Children With Tumor Mutational Burden–High Solid Tumors
On June 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high (TMB-H; ≥ 10 mutations/megabase [mut/Mb]) solid tumors, as determined by an ...
FDA Extends Indication of Gemtuzumab Ozogamicin for Pediatric Patients With CD33-Positive AML
On June 16, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients aged 1 month and older. AAML0531 Efficacy and safety in the pediatric population were...
